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Surgical outcomes after neoadjuvant avelumab with or without chemotherapy for Muscle-Invasive bladder cancer: a
Georges Mjaess1, Thierry Quackels1, Jean-Christophe Fantoni2
1Department of Urology, Erasme Hospital and Jules Bordet Institute, Hôpital Universitaire de Bruxelles, Université Libre de Bruxelles (ULB) Brussels, Route de Lennik 808, 1070, Brussels, Belgium.
Purpose:
Neoadjuvant chemo-immunotherapy is emerging as promising strategy in muscle-invasive bladder cancer (MIBC), yet its perioperative safety remains understudied. This post-hoc analysis of the AURA phase-II trial assesses surgical outcomes following neoadjuvant avelumab with or without chemotherapy.
Methods:
We analyzed 88 patients with localized MIBC from the phase 2 multicenter AURA trial (NCT03674424) who underwent radical cystectomy after receiving either avelumab monotherapy (n = 22) or chemo-immunotherapy (n = 66). Surgical complications were classified using Clavien-Dindo criteria. A LASSO regression was used to identify predictors of overall complications, followed by multivariable and mixed-effects models.
Results:
No increased intra-operative surgical complexity was noted. The overall complication rate was 52%. Major complications occurred significantly more often in the chemo-immunotherapy group compared to monotherapy (21.2% vs. 15.4%, p = 0.03), despite more favorable patient profiles. Neobladder diversion and open surgery were both associated with higher complication rates (81% vs. ileal conduit 40%, p = 0.001; 61% vs. robotic surgery 53%, p = 0.04, respectively). Uretero-enteric stricture occurred in 7.6% of patients, with no significant difference between groups. The predictive model demonstrated high accuracy (AUC 0.851) and identified key risk factors for major complications: neobladder reconstruction (OR 10.9[2.4-48.4], p = 0.002), older age, longer operative time, and low preoperative hemoglobin. Limitations include the non-randomized treatment allocation and small sample size in the monotherapy group, which may limit generalizability.
Conclusion:
Radical cystectomy after neoadjuvant immunotherapy+/-chemotherapy is feasible, safe, and is not associated with increased intra-operative surgical complexity. Neoadjuvant chemo-immunotherapy prior to cystectomy was associated with increased risk of major surgical complications compared to immunotherapy alone.
Insights
Neoadjuvant chemo-immunotherapy for muscle-invasive bladder cancer (MIBC) is feasible but linked to more major surgical complications than immunotherapy alone. Radical cystectomy after neoadjuvant therapy is safe, with no increased intra-operative complexity.
Area of Science:
- Uro-oncology
- Surgical oncology
- Immunotherapy
Background:
- Neoadjuvant chemo-immunotherapy shows promise for muscle-invasive bladder cancer (MIBC).
- Perioperative safety of neoadjuvant immunotherapy in MIBC requires further study.
- Radical cystectomy is a standard treatment for localized MIBC.
Purpose of the Study:
- To assess surgical outcomes and perioperative safety after neoadjuvant avelumab with or without chemotherapy in MIBC patients.
- To evaluate the feasibility and safety of radical cystectomy following neoadjuvant immunotherapy.
- To identify predictors of surgical complications after neoadjuvant therapy for MIBC.
Main Methods:
- Post-hoc analysis of 88 MIBC patients from the AURA phase-II trial (NCT03674424).
- Patients received either avelumab monotherapy (n=22) or chemo-immunotherapy (n=66) before radical cystectomy.
- Surgical complications were graded using Clavien-Dindo criteria; LASSO regression identified complication predictors.
Main Results:
- No increased intra-operative surgical complexity was observed.
- Overall complication rate was 52%, with higher major complication rates in the chemo-immunotherapy group (21.2% vs. 15.4%, p=0.03).
- Neobladder diversion (81% vs. 40%) and open surgery (61% vs. 53%) were associated with higher complication rates. Key predictors for major complications included neobladder reconstruction (OR 10.9), older age, longer operative time, and low preoperative hemoglobin.
Conclusions:
- Radical cystectomy following neoadjuvant immunotherapy +/- chemotherapy is feasible and safe.
- Neoadjuvant chemo-immunotherapy is associated with an increased risk of major surgical complications compared to immunotherapy alone.
- Predictive models can identify patients at higher risk for complications, aiding surgical planning.
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